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The overall objective of this study is to assess the efficacy and safety of two dosing regimens of gemcabene (300 mg once daily for 24 weeks or 300 mg daily for 12 weeks followed by 600 mg daily for 12 weeks) in up to eight patients with Familial Partial Lipodystrophy with high triglycerides and Non-Alcoholic Fatty Liver Disease. The study will consist of a six week Wash Out Period, up to a 28 day Screening Period, a 24 week Treatment Period, and a follow-on safety assessment four weeks post final dose. Study participation will last approximately 4 months and includes at least 9 study visits, and can be as many as 11 study visits.
Patients with typical Familial Partial Lipodystrophy Disease (FPLD) have a marked loss of subcutaneous fat from the extremities and trunk accompanied by a variable amount of excess fat deposition in the nonlipodystrophic areas such as the face, chin, back, and intraabdominal regions. Dietary fat restriction and other lifestyle changes are first line therapy to avoid weight gain, critical for effective management of metabolic complications in patients with lipodystrophy. However, despite lifestyle changes and conventional hypoglycemic and hypolipidemic therapies, some FPLD patients continue to have extreme hypertriglyceridemia, hepatic steatosis, and poorly controlled diabetes.Hypertriglyceridemia is a common condition of FPLD and serum triglyceride levels of 250-1999 mg/dL, classified as moderate to severe hypertriglyceridemia, indicate risk for development of very severe hypertriglyceridemia, causative of pancreatitis and hepatic steatosis. In patients such as those with FPLD with severe or very severe hypertriglyceridemia, fibrates, omega-3 fatty acids (OMG-3) and occasionally niacin are first-line therapy. Non-alcoholic fatty liver disease (NAFLD) is often associated with FPLD. The spectrum of NAFLD associated with FPLD which appears to be more frequent than what is seen in common Type 2 diabetes and appears more severe than common forms of NAFLD and very often associated with NASH. The etiology for the latter is not clear, however, the fact that a mouse model of liver specific laminopathy develops NASH in a cell -autonomous manner suggests that the specific cellular defects seen in FPLD may play a role in the development of NAFLD/NASH. Triglyceride content in the liver is regulated by fatty acid uptake as well as fatty acid and VLDL production rates. Derangements in these processes, such as excessive production of fatty acids and triglycerides that can occur with excessive carbohydrate consumption contribute to NAFLD. Patients with NAFLD compared to controls, present with an atherogenic dyslipidemic profile, characterized by increased serum levels of triglycerides, ApoB, VLDL-C, and LDL-C with a proportionally greater content of small dense LDL-C (sdLDL-C) 18-20. NAFLD is also associated with aberrant nuclear receptor function and systemic inflammation. NAFLD can progress to NASH. NASH is marked by hepatocyte ballooning and liver inflammation, which may progress to scarring and irreversible damage. Macro and microscopically, NASH is characterized by lobular and/or portal inflammation, varying degrees of fibrosis, hepatocyte death and pathological angiogenesis. At its most severe, NASH can progress to cirrhosis, hepatocellular carcinoma (HCC) and liver failure. It is estimated that 20-33% NAFLD patients will progress to NASH, with about 5% ultimately progressing to cirrhosis. Cirrhosis has a reported 7- to 10-year mortality of 12-25%. As NAFLD and NASH continue to be a growing epidemic, gemcabene's clinical and preclinical data suggest that this novel agent may provide benefit to patients with the diagnosis of NAFLD and/or NASH. As such, further development of gemcabene may help meet an unmet medical need in these patient populations. In Phase 2 studies, gemcabene has shown triglyceride lowering from 20 to > 50% based on dose and severity of hypertriglyceridemia and lowering in hsCRP of up to 50%. Additionally, in animal and cell based models, gemcabene studies have provided evidence demonstrating: reduction in de-novo lipogenesis, reduction in intrahepatic TG levels, modulation of inflammation and reduction of the NAFLD activity score, particularly related to hepatic ballooning, steatosis, fibrosis, and collagen accumulation. As such gemcabene may have utility in hypertriglyceridemia of FLP and ultimately in the prevention or treatment of NASH in these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: 300 mg Gemcabene daily week 12-24 | Experimental | Patients took Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients were randomized 1:1 according to pre-generated randomization code. This arm received 300mg Gemcabene daily for 12 weeks total, starting at week 12. |
|
| Group 2: 600mg Gemcabene daily week 12-24 | Experimental | Patients took Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients were randomized 1:1 according to pre-generated randomization code. This arm received 600mg Gemcabene daily for 12 weeks total, starting at week 12. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 300mg Gemcabene | Drug | 300mg Gemcabene |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fasting Serum Triglyceride (at 12 Weeks) | This is measured by percent change in fasting serum triglyceride from baseline to week 12 | Baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fasting Serum Triglycerides (Through 24 Weeks) | This is measured by change in fasting serum triglyceride from baseline to average of weeks 6 and 12, and week 24 and change in fasting serum triglyceride from baseline to week 12 | Baseline, week 6 and week 12, week 24 |
| Percent Change in Fasting Serum Triglycerides (Through 24 Weeks) |
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| Name | Affiliation | Role |
|---|---|---|
| Elif A Oral, M.D. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48105 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: 300 mg Gemcabene Daily Week 1-24 | Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12. 300mg Gemcabene: 300mg Gemcabene |
| FG001 | Group 2: 600mg Gemcabene Daily Week 12-24 | Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12. 600mg Gemcabene: 600mg Gemcabene |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: 300 mg Gemcabene Daily Week 1-24 | Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12. 300mg Gemcabene: 300mg Gemcabene |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Fasting Serum Triglyceride (at 12 Weeks) | This is measured by percent change in fasting serum triglyceride from baseline to week 12 | Posted | Mean | Full Range | percent change | Baseline to week 12 |
|
28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: 300 mg Gemcabene Daily Week 1-24 | Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12. 300mg Gemcabene: 300mg Gemcabene |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Nervous system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increase in liver fat | Hepatobiliary disorders | Non-systematic Assessment |
The expected number of study subjects (8), was not reached.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elif Oral | University of Michigan | 734-615-7271 | eliforal@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 11, 2019 | May 12, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D052496 | Lipodystrophy, Familial Partial |
| D015228 | Hypertriglyceridemia |
| D005234 | Fatty Liver |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D000083083 | Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008060 | Lipodystrophy |
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| ID | Term |
|---|---|
| C111024 | gemcabene |
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| 600mg Gemcabene |
| Drug |
600mg Gemcabene |
|
This is measured by percent change in fasting serum triglyceride from baseline to average of weeks 6 and 12, and week 24 and change in fasting serum triglyceride from baseline to week 12 |
| Baseline, week 6 and week 12, week 24 |
| Change in Liver Fat Content as Measured by Magnetic Resonance Imaging - Protein Density Fat Fraction (MRI-PDFF) | This is measured by change in liver fat content using Magnetic Resonance Imaging - Protein Density Fat Fraction (MRI-PDFF) from baseline to week 12 and week 24 | Baseline, week 12, week 24 |
| Percent Change in Liver Fat Content as Measured by Magnetic Resonance Imaging - Protein Density Fat Fraction (MRI-PDFF) | This is measured by percent change in liver fat content using Magnetic Resonance Imaging - Protein Density Fat Fraction (MRI-PDFF) from baseline to week 12 and week 24 | Baseline, week 12, week 24 |
| Change in Liver Fibrosis | This is measured by change in liver fibrosis using MR-elastography from baseline to week 12 and week 24 | Baseline, Week 12, and Week 24 |
| Percent Change in Liver Fibrosis | This is measured by percent change in liver fibrosis using MR-elastography from baseline to week 12 and week 24 | Baseline, Week 12, and Week 24 |
| Change in NAS (Non-alcoholic Steatohepatitis) | This is measured by change in NAS via non-alcoholic fatty liver disease activity score. NAS is the unweighted sum of steatosis, lobular inflammation and hepatocyte ballooning from baseline to week 24. Total NAS scores can range from 0 to 8. The higher the NAS score, the more severe the liver disease. | Baseline to week 24 |
| Percent Change in NAS (Non-alcoholic Steatohepatitis) | This is measured by change in NAS via non-alcoholic fatty liver disease activity score. NAS is the unweighted sum of steatosis, lobular inflammation and hepatocyte ballooning from baseline to week 24. Total NAS scores can range from 0 to 8. The higher the NAS score, the more severe the liver disease. | Baseline to week 24 |
| Change in Cholesterol | This will be measured by change in total, HDL and LDL levels in mg/dL | Baseline, week 6 and week 12, week 24 |
| Percent Change in Cholesterol | This will be measured as percent change in total, HDL and LDL levels in mg/dL. | Baseline, week 6 and week 12, week 24 |
| Change in Apolipoprotein | This will be measured by change in apolipoprotein A and B in mg/dL | Baseline, week 6 and week 12, week 24 |
| Percent Change in Apolipoprotein | This will be measured by percent change in apolipoprotein A and B in mg/dL | Baseline, week 6 and week 12, week 24 |
| Change in High-Sensitivity C-Reactive Protein (hsCRP) | This is measured by change in high-sensitivity C-reactive protein (hsCRP) from baseline to weeks 12 and week 24 | Baseline, week 12, week 24 |
| Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) | This is measured by percent change in high-sensitivity C-reactive protein (hsCRP) from baseline to weeks 12 and week 24 | Baseline, week 12, week 24 |
| Change in Alanine Aminotransferase (ALT) | This is measured by change in alanine aminotransferase (ALT) from baseline to weeks 12 and week 24 | Baseline, week 12, week 24 |
| Percent Change in Alanine Aminotransferase (ALT) | This is measured by percent change in alanine aminotransferase (ALT) from baseline to weeks 12 and week 24 | Baseline, week 12, week 24 |
| Change in Aspartate Aminotransferase (AST) | This is measured by change in aspartate aminotransferase (AST) from baseline to weeks 12 and week 24 | Baseline, week 12, week 24 |
| Percent Change in Aspartate Aminotransferase (AST) | This is measured by percent change in aspartate aminotransferase (AST) from baseline to weeks 12 and week 24 | Baseline, week 12, week 24 |
| BG001 | Group 2: 600mg Gemcabene Daily Week 12-24 | Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12. 600mg Gemcabene: 600mg Gemcabene |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Fasting Serum Triglycerides | Patient's fasting serum triglycerides measured in mg/dL. | Mean | Full Range | mg/dL |
|
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12.
600mg Gemcabene: 600mg Gemcabene
|
|
|
| Secondary | Change in Fasting Serum Triglycerides (Through 24 Weeks) | This is measured by change in fasting serum triglyceride from baseline to average of weeks 6 and 12, and week 24 and change in fasting serum triglyceride from baseline to week 12 | Posted | Mean | Full Range | mg/dL | Baseline, week 6 and week 12, week 24 |
|
|
|
| Secondary | Percent Change in Fasting Serum Triglycerides (Through 24 Weeks) | This is measured by percent change in fasting serum triglyceride from baseline to average of weeks 6 and 12, and week 24 and change in fasting serum triglyceride from baseline to week 12 | Posted | Mean | Full Range | percent change | Baseline, week 6 and week 12, week 24 |
|
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|
| Secondary | Change in Liver Fat Content as Measured by Magnetic Resonance Imaging - Protein Density Fat Fraction (MRI-PDFF) | This is measured by change in liver fat content using Magnetic Resonance Imaging - Protein Density Fat Fraction (MRI-PDFF) from baseline to week 12 and week 24 | Posted | Mean | Full Range | % PDFF | Baseline, week 12, week 24 |
|
|
|
| Secondary | Percent Change in Liver Fat Content as Measured by Magnetic Resonance Imaging - Protein Density Fat Fraction (MRI-PDFF) | This is measured by percent change in liver fat content using Magnetic Resonance Imaging - Protein Density Fat Fraction (MRI-PDFF) from baseline to week 12 and week 24 | Posted | Mean | Full Range | percent change in liver fat | Baseline, week 12, week 24 |
|
|
|
| Secondary | Change in Liver Fibrosis | This is measured by change in liver fibrosis using MR-elastography from baseline to week 12 and week 24 | Percentage of change in Preliminary Hepatic Fat-Fraction (PDFF) | Posted | Mean | Full Range | kPA | Baseline, Week 12, and Week 24 |
|
|
|
| Secondary | Percent Change in Liver Fibrosis | This is measured by percent change in liver fibrosis using MR-elastography from baseline to week 12 and week 24 | Posted | Mean | Full Range | percent change in fibrosis | Baseline, Week 12, and Week 24 |
|
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|
| Secondary | Change in NAS (Non-alcoholic Steatohepatitis) | This is measured by change in NAS via non-alcoholic fatty liver disease activity score. NAS is the unweighted sum of steatosis, lobular inflammation and hepatocyte ballooning from baseline to week 24. Total NAS scores can range from 0 to 8. The higher the NAS score, the more severe the liver disease. | Liver biopsy was performed in two participants at baseline (1 subject in group-1 and another subject in group-2). Paired liver biopsy was only available for the subject in group-1. | Posted | Mean | Full Range | scores on a scale (NAFLD activity score) | Baseline to week 24 |
|
|
|
| Secondary | Percent Change in NAS (Non-alcoholic Steatohepatitis) | This is measured by change in NAS via non-alcoholic fatty liver disease activity score. NAS is the unweighted sum of steatosis, lobular inflammation and hepatocyte ballooning from baseline to week 24. Total NAS scores can range from 0 to 8. The higher the NAS score, the more severe the liver disease. | Posted | Mean | Full Range | percent change | Baseline to week 24 |
|
|
|
| Secondary | Change in Cholesterol | This will be measured by change in total, HDL and LDL levels in mg/dL | Posted | Mean | Full Range | mg/dL | Baseline, week 6 and week 12, week 24 |
|
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|
| Secondary | Percent Change in Cholesterol | This will be measured as percent change in total, HDL and LDL levels in mg/dL. | Posted | Mean | Full Range | percent change | Baseline, week 6 and week 12, week 24 |
|
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|
| Secondary | Change in Apolipoprotein | This will be measured by change in apolipoprotein A and B in mg/dL | Posted | Mean | Full Range | mg/dL | Baseline, week 6 and week 12, week 24 |
|
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| Secondary | Percent Change in Apolipoprotein | This will be measured by percent change in apolipoprotein A and B in mg/dL | % Change in participants in group A and group B | Posted | Mean | Full Range | percent change | Baseline, week 6 and week 12, week 24 |
|
|
|
| Secondary | Change in High-Sensitivity C-Reactive Protein (hsCRP) | This is measured by change in high-sensitivity C-reactive protein (hsCRP) from baseline to weeks 12 and week 24 | Posted | Mean | Full Range | mg/dL | Baseline, week 12, week 24 |
|
|
|
| Secondary | Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) | This is measured by percent change in high-sensitivity C-reactive protein (hsCRP) from baseline to weeks 12 and week 24 | Posted | Mean | Full Range | percent change | Baseline, week 12, week 24 |
|
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| Secondary | Change in Alanine Aminotransferase (ALT) | This is measured by change in alanine aminotransferase (ALT) from baseline to weeks 12 and week 24 | Posted | Mean | Full Range | IU/L | Baseline, week 12, week 24 |
|
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|
| Secondary | Percent Change in Alanine Aminotransferase (ALT) | This is measured by percent change in alanine aminotransferase (ALT) from baseline to weeks 12 and week 24 | Posted | Mean | Full Range | percent change | Baseline, week 12, week 24 |
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|
| Secondary | Change in Aspartate Aminotransferase (AST) | This is measured by change in aspartate aminotransferase (AST) from baseline to weeks 12 and week 24 | Posted | Mean | Full Range | IU/L | Baseline, week 12, week 24 |
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|
| Secondary | Percent Change in Aspartate Aminotransferase (AST) | This is measured by percent change in aspartate aminotransferase (AST) from baseline to weeks 12 and week 24 | Posted | Mean | Full Range | percent change | Baseline, week 12, week 24 |
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| 0 |
| 2 |
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | Group 2: 600mg Gemcabene Daily Week 12-24 | Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12. 600mg Gemcabene: 600mg Gemcabene | 0 | 3 | 1 | 3 | 3 | 3 |
| Upper Respiratory Infection | Infections and infestations | Non-systematic Assessment |
|
| Increased Muscle Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Arthritis of thumb | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Bloating | Gastrointestinal disorders | Non-systematic Assessment |
|
| Cellulitis on R finger | Infections and infestations | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Increase in Creatinine Phosphokinase | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Increased Hunger | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Increased Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Kidney Stones | Renal and urinary disorders | Non-systematic Assessment |
|
| Pain from Liver Bx | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | Non-systematic Assessment |
|
| Sore Throat | Infections and infestations | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Body Pain | General disorders | Non-systematic Assessment |
|
| Decreased EGFR non-black | Renal and urinary disorders | Non-systematic Assessment |
|
| dizzyness 'spell' has history of these last episode ago 1 year | Nervous system disorders | Non-systematic Assessment |
|
| Dry skin itchniness | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Fall down steps | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| GERD | Gastrointestinal disorders | Non-systematic Assessment |
|
| Headache (migraine) | Nervous system disorders | Non-systematic Assessment |
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| HSV Outbreak | Infections and infestations | Non-systematic Assessment |
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| hypoglycemia | Endocrine disorders | Non-systematic Assessment |
|
| increase in calcium level (lab) | Endocrine disorders | Non-systematic Assessment |
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| Increase in fatigue | General disorders | Non-systematic Assessment |
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| Increased Blood Sugars | Endocrine disorders | Non-systematic Assessment |
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| Increased Creatinine | Renal and urinary disorders | Non-systematic Assessment |
|
| increased CRP | Immune system disorders | Non-systematic Assessment |
|
| Increased diabetic neuropathy | Nervous system disorders | Non-systematic Assessment |
|
| Increased GGTP | Hepatobiliary disorders | Non-systematic Assessment |
|
| Increased headaches | Nervous system disorders | Non-systematic Assessment |
|
| increased liver enzymes | Hepatobiliary disorders | Non-systematic Assessment |
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| increased pain hips (arthritis) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Increased stress levels | General disorders | Non-systematic Assessment |
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| Lesion L side of mouth | Investigations | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Pain increased knees both (arthritis bath) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Shoulder soreness/stiffness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Stomach pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| upper right quadrant pain of abdomen | General disorders | Non-systematic Assessment |
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| vomited (intermittent) | Gastrointestinal disorders | Non-systematic Assessment |
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| weight loss | Metabolism and nutrition disorders | Non-systematic Assessment |
|
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| D012875 | Skin Diseases, Metabolic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008052 | Lipid Metabolism, Inborn Errors |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |